Cleared Traditional

K253911 - Derma-2 (FDA 510(k) Clearance)

Class I Radiology device.

K253911 · Neko Health AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
163d
Days
Class 1
Risk

K253911 is an FDA 510(k) clearance for the Derma-2. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Neko Health AB (Danderyd, SE). The FDA issued a Cleared decision on May 20, 2026 after a review of 163 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2980 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Neko Health AB devices

Submission Details

510(k) Number K253911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2025
Decision Date May 20, 2026
Days to Decision 163 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 107d · This submission: 163d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LHQ System, Telethermographic (adjunctive Use)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.2980
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Healthcare Innovation Catalysts, Inc.
Brittany Valdez Nava

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LHQ System, Telethermographic (adjunctive Use)

All 40
Devices cleared under the same product code (LHQ) and FDA review panel - the closest regulatory comparables to K253911.
ThermPix Thermovisual Camera
K232462 · Usa Therm, Inc. · Sep 2023
ThermPix Thermovisual Camera
K213650 · Usa Therm, Inc. · Apr 2022
Smile-100 System
K212965 · Niramai Health Analytix Private Limited · Mar 2022
IRIS-XP
K212412 · Medicore Co., Ltd. · Sep 2021
Thermidas IR System (ThIR-A615)
K200999 · Thermidas Americas, Inc. · Jan 2021
InTouch Thermal Camera
K181716 · Intouch Technologies, Inc., D.B.A. Intouch Health · Mar 2019